PRA, Takeda form new Japan JV as CRO integrates more deeply

After announcing a never-before-seen deal last fall that saw contract research organization PRA Health integrate itself into Takeda’s research business, the original pact has been expanded as the CRO will now also work with the Big Pharma in its native Japan under a joint venture deal.

Last September, Takeda announced the major shake-up of its clinical and drug development as it moved hundreds of its staff over to PRA Health, with the intention of it taking control of much of its operations in the U.S. and Europe.

The first part of this deal saw the Raleigh, North Carolina-based CRO take the lead on Takeda’s marketed products, clinical development and postapproval needs, and also saw PRA manage an entire pipeline of studies for Takeda, across all phases of human development and after approval, while also providing regulatory, drug safety and other operational services for both development and marketed product portfolios.

This meant that around 300 Takeda employees who had been supporting drug development and marketed products for the company were “given the opportunity to transition to PRA” in the U.S. and Europe, Takeda said at the time.

But talks over its Japanese employees were still ongoing between the two companies, and was always to prove a trickier transition, given that this is its native country.

Five months down the line, however, the Big Pharma has made another major decision that creates a new joint venture between Takeda and PRA, with each holding 50% of the share respectively, to “provide clinical trial delivery and pharmacovigilance services as a strategic partner of Takeda in Japan,” according to a statement from the pair.

This new unit is slated to come into being in the first quarter and be ready for ops by the second quarter, and will see the transfer of around 140 Takeda employees, who will continue “to support drug development and marketed products in Japan.”

Takeda will also transfer all of the shares of Takeda Pharmaceutical Data Services, a wholly owned subsidiary of the pharma, to PRA in the second quarter, with around 60 employees “supporting Takeda Development Center Japan.” As before, the company has not spoken of any cuts coming out of this new deal.

This JV, which in essence is giving much of its trial work over to PRA, will manage an entire portfolio of studies for Takeda, across all phases of development, while also providing pharmacovigilance and other operational services for both development and marketed product portfolios, all in “close alignment” with the Takeda Development Center Japan.

Takeda is already in the middle of retooling its R&D, announcing back in the summer that it would accelerate its reorganization of its R&D units in the U.S. and Japan to focus on three therapy areas—oncology, gastroenterology and central nervous system—while also shutting down or de-emphasizing other overseas R&D centers.

It has also taken a keen interest in U.S. biopharmas, spending over $5 billion last month on cancer biotech Ariad, as well as paying $125 million for a T-cell research deal with biotech Maverick that comes with a 5-year buyout clause.

That came a week after Takeda, in a similar deal structure, said it would pay $35 million for tiny, early-stage PvP Biologics in a GI pact, with an acquisition also here on the cards.

And late last year, Takeda and VC Lightstone came together to launch Cerevance, a new company focused on neuroscience R&D for neurological and psychiatric disorders that will get the help of U.K. scientists (a country it had looked to largely exit from) and be headed up by biotech vet Brad Margus.

Takeda’s shares, which are traded in Japan, were up marginally on the news on Wednesday by around 0.5%. PRA Health is set to release its fourth-quarter and full year financials on 22 Feb.